Every day research uncovers new information about medical conditions and possible therapies. Those who volunteer in medical research are participating in the testing, understanding and development of new medical treatments. Volunteers are important to the clinical study phase of a drug approval process.
What is a Clinical Trial?
A clinical trial is an important step in making new medications available. Each trial is designed to test new investigational drugs for safety, effectiveness and side effects. Clinical trial participants help researchers in furthering the development of new treatments for multiple sclerosis.
Who can Participate in a Clinical Trial?
Each trial has strict requirements for participation such as age, current health and past medical history. These requirements are called inclusion and exclusion criteria. The physician and research coordinator conducting the trial will review each possible participant’s medical history and the requirements of the study to determine who is eligible. Known risks, discomforts, and procedures associated with the trial medication are explained by the research team. In addition to the known risks, there may be unknown risks such as side effects of the research medication. All trial procedures, risks and any potential benefits are explained and outlined to potential participants in the letter of information and consent form.
What is Informed Consent?
Informed consent is a process outlining the information necessary to make a decision about participating in a clinical trial. The informed consent document and letter of information explains the details of the trial, such as its purpose, the length of the study, required procedures during the trial, and contacts within the research team throughout the trial.
During the informed consent process potential participants are given the opportunity to ask questions and exchange information with the research team. It is important to take the document home to discuss with family, friends and/or the family physician prior to making a commitment to the study.
How are the Rights and Safety of Trial Participants Protected?
Every research study is approved and monitored by the Health Sciences Research Ethics Board. This group of healthcare professionals and members of the community ensure a research trial is ethical and that the safety and rights of participants are protected.
All universities, hospitals and other institutions that conduct or support human research must have the research approved by the Health Sciences Research Board.
Considering Volunteering for Clinical Research?
Volunteering for clinical research provides participants with opportunities to contribute to society, the community, as well as others who have multiple sclerosis. As a volunteer, the investigating physician and the research staff will always safeguard your health and best interest first and foremost. Here are some questions to ask before volunteering for research:
- What are the potential benefits, and foreseeable risks and discomfort?
- How long will I be in the study?
- How often will I need to visit the clinic?
- What tests will be done at the visits?
- Is there a chance of receiving a placebo?
- How many people have taken the study drug?
- Will it cost me anything to participate in the study?
- What are my treatment options if I do not participate in the study?
- Will I continue to see my own family doctor during the study?
- Will I learn of the study results? If so, when?